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Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Primary Purpose

HIV, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Stribild
Atripla
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV focused on measuring HIV, HIV-1, Antiretroviral Treatment-Naive, treatment naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Plasma HIV-1 RNA levels ≥ 5,000 copies/mL
  • No prior use of any approved or experimental anti-HIV drug
  • Normal electrocardiogram (ECG)
  • Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula
  • Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin
  • Adequate hematologic function
  • Cluster determinant 4 (CD4) cell count > 50 cells/µL
  • Serum amylase ≤ 1.5 x ULN
  • Normal thyroid-stimulating hormone
  • Negative serum pregnancy test (for females of childbearing potential only)
  • Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs
  • Life expectancy ≥ 1 year
  • Ability to understand and sign a written informed consent form

Exclusion Criteria:

  • New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening
  • Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s)
  • Hepatitis B surface antigen positive
  • Hepatitis C antibody positive
  • Participants experiencing cirrhosis
  • Participants experiencing ascites
  • Participants experiencing encephalopathy
  • Females who are breastfeeding
  • Positive serum pregnancy test (for females of childbearing potential)
  • Vaccinated within 90 days of study dosing
  • History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30
  • Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
  • Prolonged QTcF interval at screening
  • PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening
  • QRS ≥ 120 msec on ECG at screening
  • Implanted defibrillator or pacemaker
  • Participants receiving ongoing therapy with any disallowed medications
  • Current alcohol or substance use judged to potentially interfere with participant study compliance
  • History of or ongoing malignancy (including untreated carcinoma in situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma
  • Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline
  • Participation in any other clinical trial without prior approval
  • Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF
  • Any known allergies to the excipients of Atripla or Stribild tablets
  • Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements

Sites / Locations

  • Health for Life Clinic, PLLC
  • The Living Hope Foundation
  • Peter J. Ruane, MD, Inc.
  • Orange Coast Medical Group
  • East Bay AIDS Center
  • Metropolis Medical
  • Apex Research Institute
  • Dupont Circle Physicians Group
  • Whitman Walker Clinic
  • Capital Medical Associates PC
  • Broward Health
  • Gary Richmond, MD, PA, Inc.
  • Wohlfeiler, Piperato and Associates, LLC
  • Orlando Immunology Center
  • Infectious Disease of Central Florida
  • Treasure Coast Infectious Disease Consultants
  • Infectious Disease Specialists of Atlanta (IDSA)
  • Northstar Medical Center
  • Chase Brexton Health Services, Inc.
  • Community Research Initiative of New England
  • Be Well Medical Center
  • Southampton Healthcare, Inc.
  • Southwest C.A.R.E. Center
  • Chelsea Village Medical
  • Ricky K. Hsu, MD, PC
  • Rosedale Infectious Diseases
  • Nicholaos Bellos, MD, PA
  • AIDS Arms/ Peabody Health Center
  • Gordon E. Crofoot, MD, PA
  • TribalMed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stribild

Atripla

Arm Description

Outcomes

Primary Outcome Measures

The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.

Secondary Outcome Measures

The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Change = Week 24 or 48 value minus baseline value
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Change = Week 24 value minus baseline value
Change From Baseline in CD4 Cell Count at Week 48
Change = Week 48 value minus baseline value
The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL
The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.

Full Information

First Posted
March 24, 2009
Last Updated
May 22, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00869557
Brief Title
Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Official Title
A Phase 2, Randomized, Double-Blinded Study of the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Atripla® (Efavirenz 600 mg/Emtricitabine 200 mg/Tenofovir Disoproxil Fumarate 300 mg) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The objective of this double-blinded, multicenter, randomized, active-controlled study is to evaluate the safety and efficacy of Stribild, a single-tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus efavirenz (EFV)/FTC/TDF (Atripla) in HIV-1 infected, antiretroviral treatment-naive adult participants. Stribild offers an alternative STR for patients who are not candidates for non-nucleoside reverse transcriptor (NNRTI)-based STRs. Participants will be randomized in a 2:1 ratio to receive Stribild or Atripla. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL) at screening. After Week 48, participants will continue to take their blinded study drug and attend visits every 12 weeks until treatment assignments are unblinded (Week 60), at which point all participants will attend an Unblinding Visit and be given the option to participate in an open-label rollover extension (the extension is scheduled to be open until Stribild becomes commercially available, or until Gilead Sciences elects to terminate the study).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
HIV, HIV-1, Antiretroviral Treatment-Naive, treatment naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stribild
Arm Type
Experimental
Arm Title
Atripla
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Stribild
Intervention Description
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily (QD) + placebo to match Atripla once daily prior to bedtime (QHS)
Intervention Type
Drug
Intervention Name(s)
Atripla
Intervention Description
Atripla (EFV 150 mg/FTC 200mg/TDF 300 mg) STR QHS + placebo to match Stribild QD
Primary Outcome Measure Information:
Title
The Percentage of Participants With HIV-1 Ribonucleic Acid (RNA) Less Than 50 Copies/mL at Week 24
Description
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 24 was summarized.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
The Percentage of Participants With HIV-1 RNA Less Than 50 Copies/mL at Week 48
Description
The percentage of participants with plasma HIV-1 RNA < 50 copies/mL at Week 48 was summarized.
Time Frame
Week 48
Title
Change From Baseline in HIV-1 RNA (log_10 Copies/mL)
Description
Change = Week 24 or 48 value minus baseline value
Time Frame
Baseline to Weeks 24 and 48
Title
Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 24
Description
Change = Week 24 value minus baseline value
Time Frame
Baseline to Week 24
Title
Change From Baseline in CD4 Cell Count at Week 48
Description
Change = Week 48 value minus baseline value
Time Frame
Baseline to Week 48
Title
The Percentage of Participants With Virologic Success at Weeks 24 and 48 Using FDA-Defined Snapshot Analysis and HIV-1 RNA Less Than 50 Copies/mL
Description
The percentage of participants with virologic success at Weeks 24 and 48 assessed using the FDA-defined snapshot analysis for an HIV-1 RNA cutoff of 50 copies/mL was summarized.
Time Frame
Baseline to Weeks 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Plasma HIV-1 RNA levels ≥ 5,000 copies/mL No prior use of any approved or experimental anti-HIV drug Normal electrocardiogram (ECG) Adequate renal function: estimated glomerular filtration rate ≥ 80 mL/min according to the Cockcroft-Gault formula Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN) Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin Adequate hematologic function Cluster determinant 4 (CD4) cell count > 50 cells/µL Serum amylase ≤ 1.5 x ULN Normal thyroid-stimulating hormone Negative serum pregnancy test (for females of childbearing potential only) Males and females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 12 weeks following the last dose of study drugs Life expectancy ≥ 1 year Ability to understand and sign a written informed consent form Exclusion Criteria: New acquired immunodeficiency syndrome (AIDS)-defining condition diagnosed within the 30 days prior to screening Documented drug resistance to nucleoside reverse transcriptase inhibitors or nonnucleoside reverse transcriptase inhibitors or primary protease inhibitor resistance mutation(s) Hepatitis B surface antigen positive Hepatitis C antibody positive Participants experiencing cirrhosis Participants experiencing ascites Participants experiencing encephalopathy Females who are breastfeeding Positive serum pregnancy test (for females of childbearing potential) Vaccinated within 90 days of study dosing History or family history of Long QT Syndrome or family history of sudden cardiac death or unexplained death in an otherwise healthy individual under the age of 30 Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities Prolonged QTcF interval at screening PR interval ≥ 200 msec or ≤ 120 msec on ECG at screening QRS ≥ 120 msec on ECG at screening Implanted defibrillator or pacemaker Participants receiving ongoing therapy with any disallowed medications Current alcohol or substance use judged to potentially interfere with participant study compliance History of or ongoing malignancy (including untreated carcinoma in situ) other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline Participation in any other clinical trial without prior approval Medications contraindicated for use with EFV, EVG, COBI, FTC, or TDF Any known allergies to the excipients of Atripla or Stribild tablets Any other clinical condition or prior therapy that would make the participant unsuitable for the study or unable to comply with the dosing requirements
Facility Information:
Facility Name
Health for Life Clinic, PLLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
The Living Hope Foundation
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Peter J. Ruane, MD, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Orange Coast Medical Group
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
East Bay AIDS Center
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Metropolis Medical
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Apex Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Whitman Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Capital Medical Associates PC
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20036
Country
United States
Facility Name
Broward Health
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Gary Richmond, MD, PA, Inc.
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Wohlfeiler, Piperato and Associates, LLC
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33139
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Infectious Disease of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
Infectious Disease Specialists of Atlanta (IDSA)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northstar Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Chase Brexton Health Services, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Be Well Medical Center
City
Berkley
State/Province
Michigan
ZIP/Postal Code
48072
Country
United States
Facility Name
Southampton Healthcare, Inc.
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63139
Country
United States
Facility Name
Southwest C.A.R.E. Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Chelsea Village Medical
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Ricky K. Hsu, MD, PC
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Rosedale Infectious Diseases
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Nicholaos Bellos, MD, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
AIDS Arms/ Peabody Health Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75215
Country
United States
Facility Name
Gordon E. Crofoot, MD, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77098
Country
United States
Facility Name
TribalMed
City
Seattle
State/Province
Washington
ZIP/Postal Code
98103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21412057
Citation
Cohen C, Elion R, Ruane P, Shamblaw D, DeJesus E, Rashbaum B, Chuck SL, Yale K, Liu HC, Warren DR, Ramanathan S, Kearney BP. Randomized, phase 2 evaluation of two single-tablet regimens elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate versus efavirenz/emtricitabine/tenofovir disoproxil fumarate for the initial treatment of HIV infection. AIDS. 2011 Mar 27;25(6):F7-12. doi: 10.1097/QAD.0b013e328345766f.
Results Reference
result
Links:
URL
http://www.gilead.com/
Description
Gilead Sciences

Learn more about this trial

Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

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